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Nrf2 Activator

Omaveloxolone for Friedreich's Ataxia

Phase 2
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have genetically confirmed Friedreich's ataxia
Be male or female and ≥16 years of age and ≤40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after participant receives the first dose in part 1
Awards & highlights

Study Summary

This trial is testing a drug called omaveloxolone (RTA 408) to see if it is safe and effective in treating Friedreich's ataxia, a cerebellar ataxia caused by an expansion of a certain trinucleotide repeat. The study will be conducted in two parts, with the first part testing different doses of the drug to see what the safe range is, and the second part testing the efficacy of the 150 mg dose. The trial will also have an extension to assess the long-term safety and tolerability of the drug.

Who is the study for?
This trial is for people aged 16-40 with genetically confirmed Friedreich's ataxia, who can swallow capsules and have a specific level of disease severity (modified FARS score between 20 and 80). Participants should be stable in their exercise routine and able to complete maximal exercise testing. They cannot join if they've used certain drugs recently, have significant heart disease or abnormal blood tests, uncontrolled diabetes, cognitive impairments, active infections, or substance abuse issues.Check my eligibility
What is being tested?
The study examines omaveloxolone (RTA 408) capsules at various doses for treating Friedreich's ataxia. It has two parts: the first part tests safety across different doses; the second part assesses safety and effectiveness of a set dose (150 mg). An extension phase will look into long-term use. The drug aims to activate Nrf2 signaling impaired in this condition.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to oxidative stress mitigation since omaveloxolone activates antioxidant pathways. These could involve changes in energy levels, gastrointestinal symptoms or possible liver enzyme alterations given its mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is genetically confirmed Friedreich's ataxia.
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I am between 16 and 40 years old.
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My FARS score is between 20 and 80.
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I can swallow pills.
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I can swallow pills.
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I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 12 weeks after participant receives the first dose in part 1.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 weeks after participant receives the first dose in part 1. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1
Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2
Secondary outcome measures
Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Omaveloxolone Capsules 150 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Group II: Part 1 Omaveloxolone Capsules 80 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Group III: Part 1 Omaveloxolone Capsules 40 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Group IV: Part 1 Omaveloxolone Capsules 300 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Group V: Part 1 Omaveloxolone Capsules 20 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Group VI: Part 1 Omaveloxolone Capsules 2.5 and 5 mgExperimental Treatment2 Interventions
omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks
Group VII: Part 1 Omaveloxolone Capsules 160 mgExperimental Treatment1 Intervention
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Group VIII: Part 1 Omaveloxolone Capsules 10 mgExperimental Treatment1 Intervention
omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Group IX: Part 1 Placebo CapsulesPlacebo Group1 Intervention
Placebo capsules administered orally once daily for 12 weeks
Group X: Part 2 Placebo CapsulesPlacebo Group1 Intervention
Placebo capsules administered orally once daily for 48 weeks

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,262 Total Patients Enrolled
2 Trials studying Friedreich Ataxia
164 Patients Enrolled for Friedreich Ataxia
Reata, a wholly owned subsidiary of BiogenLead Sponsor
45 Previous Clinical Trials
6,238 Total Patients Enrolled
Friedreich's Ataxia Research AllianceOTHER
16 Previous Clinical Trials
5,776 Total Patients Enrolled
16 Trials studying Friedreich Ataxia
5,776 Patients Enrolled for Friedreich Ataxia

Media Library

Omaveloxolone (Nrf2 Activator) Clinical Trial Eligibility Overview. Trial Name: NCT02255435 — Phase 2
Friedreich Ataxia Research Study Groups: Part 1 Omaveloxolone Capsules 10 mg, Part 1 Omaveloxolone Capsules 2.5 and 5 mg, Part 1 Omaveloxolone Capsules 20 mg, Part 1 Omaveloxolone Capsules 40 mg, Part 1 Omaveloxolone Capsules 80 mg, Part 1 Omaveloxolone Capsules 160 mg, Part 1 Omaveloxolone Capsules 300 mg, Part 1 Placebo Capsules, Part 2 Placebo Capsules, Part 2 Omaveloxolone Capsules 150 mg
Friedreich Ataxia Clinical Trial 2023: Omaveloxolone Highlights & Side Effects. Trial Name: NCT02255435 — Phase 2
Omaveloxolone (Nrf2 Activator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02255435 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this clinical trial?

"This medical study is no longer recruiting participants, with the latest edits being applied on November 4th 2022. As an alternative, there are currently 46 clinical trials involving Friedreich ataxia and one trial for Omaveloxolone Capsules (150 mg) that have open enrollment positions available."

Answered by AI

How many enrollees will this research endeavor feature?

"Unfortunately, no additional participants are being accepted into this clinical trial. The post was made on the first of January 2015 and last modified on the fourth of November 2022. Fortunately, 46 trials for those with Friedreich ataxia and one study for Omaveloxolone Capsules (150 mg) remain open to volunteers."

Answered by AI

What have been the observed effects of ingesting Omaveloxolone Capsules, 150 mg?

"The safety of Omaveloxolone Capsules, 150 mg was evaluated at a 2 due to the lack of clinical evidence that confirms its efficacy. However, there is some data available confirming this drug's safety."

Answered by AI

Are there any other investigations regarding the efficacy of Omaveloxolone Capsules, 150 mg?

"Omaveloxolone Capsules, 150 mg was initially trialled at Children's Hospital of Philadelphia in 2015. Since then, 18335 clinical trials have concluded with 1 presently being actively recruited from various clinics located in Tampa, Florida."

Answered by AI

Is this undertaking a pioneering venture?

"AbbVie's Omaveloxolone Capsules, 150 mg is now being tested in just one live research study spanning 5 countries and 8 cities. This pharmaceutical drug was trialled for the first time in 2015 with 172 patients - eventually reaching Phase 2 approval. Since then, 18335 additional trials have been conducted."

Answered by AI

Does my profile qualify me to partake in this clinical research?

"This clinical trial is in search of 172 people with friedreich ataxia, ranging from 16 to 40 years old. Essential criteria for consideration include a modified FARS score between 20 and 80 inclusive, male or female gender identity, capacity to swallow pills, ability to perform maximal exercise tests and no significant alteration to the current physical routine within 30 days before commencement."

Answered by AI

Does this investigation include elderly participants?

"This trial seeks volunteers aged 16 to 40; while there are 18 clinical trials for those under the legal age of consent, 33 studies exist that focus on elderly individuals."

Answered by AI

How many geographical locations has this clinical experiment been conducted in?

"The USF Ataxia Research Center in Tampa, Florida, Ohio State University - Neurology in Columbus and the University of Iowa Stead Family Children's Hospital in Iowa City are just some of the locations offering this clinical trial. There are an additional 7 research centres administering it as well."

Answered by AI

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
USF Ataxia Research Center
~17 spots leftby Mar 2025